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Patient-posture and Ileal-intubation During Colonoscopy (PIC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01159886
First received: July 9, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.


Condition Intervention
Colonoscopy
 Procedure: Ileal intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Patient-posture and Ileal-intubation During Colonoscopy (PIC): a Randomized Controlled Open-label Trial

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Ileal intubation achieved or not [ Time Frame: After confirmation of cecal intubation for no more than 6 minutes ] [ Designated as safety issue: No ]
    After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Two points will be assessed: success in ileal intubation and time taken to intubate the ileum. If ileum is not intubated within 6 minutes, it will be considered as failed attempt.


Secondary Outcome Measures:
  • Time taken to intubate the ileum after cecal intubation [ Time Frame: 6 minutes after cecal intubation and randomisation ] [ Designated as safety issue: No ]
  • Depth of ileal intubation [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
  • Influence of endoscopist experience on successful ileal intubation [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
  • Abnormal ileal findings [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: June 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: left lateral
After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus position. Then terminal ileal intubation will be attempted.
 Procedure: Ileal intubation

After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Partial suction and scope manoeuvres for ileal intubation will be allowed.

Use of anti-peristalsis agents, use of biopsy forceps, as a guidewire or an ''anchor'' to facilitate the IC- valve intubation, and intubation in the retroflexed position will not be allowed.

Other Name: Ileoscopy
Active Comparator: supine
After confirmation of cecal intubation, patient will undergo randomization to the supine position. Then terminal ileal intubation will be attempted.
 Procedure: Ileal intubation

After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Partial suction and scope manoeuvres for ileal intubation will be allowed.

Use of anti-peristalsis agents, use of biopsy forceps, as a guidewire or an ''anchor'' to facilitate the IC- valve intubation, and intubation in the retroflexed position will not be allowed.

Other Name: Ileoscopy

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult (> 12y old) patients referred for colonoscopy

Exclusion Criteria:

  • Acute fulminant colitis
  • Acute Intestinal obstruction
  • Suspected intestinal perforation
  • Peritonitis
  • Pregnancy
  • Severe cardio-respiratory disease (ASA grade…)
  • Decompensated liver disease
  • Recent pelvic or colonic surgery (in last 6 months)
  • Large aortic or ileac artery aneurysm
  • Human Immunodeficiency Virus Infection
  • Uncooperative patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159886

Contacts
Contact: Kshaunish Das, MD, DM +91 9830349787 dockdas@gmail.com

Locations
India
School of Digestive and Liver Diseases (SDLD), IPGME & R, Kolkata Recruiting
Kolkata, India, 700020
Contact: K Das            
Principal Investigator: Kshaunish Das            
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Kshaunish Das, MD, DM Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020
  More Information

No publications provided

Responsible Party: Dr Kshaunish Das, Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020
ClinicalTrials.gov Identifier: NCT01159886     History of Changes
Other Study ID Numbers: SDLD001
Study First Received: July 9, 2010
Last Updated: July 9, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
Tuberculosis
IBD
endoscopy

ClinicalTrials.gov processed this record on May 23, 2013